April 26, 2017

Case Name: Allergan, Inc. v. Teva Pharms. USA, Inc., 15-1455-WCB, 2017 U.S. Dist. LEXIS 4545 (E.D. Tex. Jan. 12, 2017) (Bryson, J.) 

Drug Product and Patent(s)-in-Suit: Restasis® (cyclosporine ophthalmic solution); U.S. Patents Nos. 8,629,111 (“the ‘111 patent”), 8,633,162 (“the ‘162 patent”), 8,642,556 (“the ‘556 patent”), 8,648,048 (“the ‘048 patent”), 8,685,930 (“the ‘930 patent”), and 9,248,191 (“the ‘191 patent”)

Nature of the Case and Issue(s) Presented: Allergan owned the patents-in-suit and marketed under the trade name Restasis a cyclosporine ophthalmic solution to treat chronic dry eye embodying the claims of the patents. Teva and the other defendants in this litigation filed ANDAs seeking to market a generic version of Allergan’s product. Allergan sued. After the deadline to amend the pleadings, Teva sought leave to amend its answer and counterclaims to assert inequitable conduct and unclean hands defenses against Allergan. Teva alleged that, to show unexpected results in support of the patents-in-suit, Allergan plagiarized data published in a medical journal a decade earlier, and that the article itself was derived from Allergan’s clinical trial data. Thus, Teva argued, Allegan’s declarations to the examiner were deceptive and misleading. The court disagreed and denied Teva’s motion to amend its answer and counterclaims.

Why Allergan Prevailed: All the factors considered in determining whether to allow late amendment to the pleadings cut against Teva. First, Teva had no explanation for its delay and, in fact, was in possession of the information underlying its motion at least four months prior to the deadline to amend. In its invalidity contentions, Teva cited to the earlier published article and pointed out the similarities between the data in the article and the data in Allergan’s declarations to the examiner. But Teva did not seek to amend its pleading at that time. Thus, the court concluded that Teva had not exercised due diligence in seeking to amend. Further, the court reasoned that Teva was unlikely to succeed on its defenses and, therefore, determined that the amendment was not important. While Allergan’s declarations did include some data from the earlier-published article, those data were not the foundation for the declarations’ conclusion that the results of the claimed invention were unexpected. Rather, the unexpectedness was premised on several other factors discussed in the declarations. Third, although discovery had yet to close, the court reasoned that adding issues of inequitable conduct and unclean hands to the case would complicate discovery. Thus, while not dispositive, this factor favored denying the amendment. Finally, the availability of a continuance provided little weight. The court noted that there is a public interest in the prompt resolution of Hatch-Waxman cases, and thus a continuance would be disfavored. For all those reasons, the Court rejected Teva’s motion to amend, finding a lack of good cause to justify the amendment.